Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
Tracking Information | |||||
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First Received Date ICMJE | July 18, 2006 | ||||
Last Updated Date | August 4, 2011 | ||||
Start Date ICMJE | November 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
The primary endpoint is the mean morning Peak Expiratory Flow (PEF) over 12 weeks recorded in the electronic Diary Record Card (eDRC). | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00353873 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Secondary measures of efficacy are: The proportion of subjects who achieve 'total-control asthma' and the proportion of subjects who achieve 'well-control asthma' | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids | ||||
Official Title ICMJE | See Detailed Description | ||||
Brief Summary | This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily. |
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Detailed Description | A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE | Asthma | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 506 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion criteria:
At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry into the run-in period and also have:
Exclusion criteria:
Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:
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Gender | Both | ||||
Ages | 4 Years to 11 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Belgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Russian Federation, Spain, Sweden | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00353873 | ||||
Other Study ID Numbers ICMJE | SAM104926 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | August 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |